510(k) · Cleared
ClearedUrgocell AG, Antimicrobial Wound Dressing with Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratoires Urgo · FRO Dressing, Wound, Drug
Cleared on Jun 11, 2010 as substantially equivalent to K061220 (Laboratoires Urgo, 2006) and 1 other predicate after a 115-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jun 11, 2010
- Review
- 115 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970566 (1997). 14 ancestors in all, the oldest K871166 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 4 generations backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- 3 generations backK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
- 2 generations backK061220 Urgotul AGLaboratoires Urgo · 2006
- 1 generation backK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
- This deviceK100429 Urgocell AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −4 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| −3 | K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X… | Coloplast Corp. | 2002 | — |
| −2 | K061220 | Urgotul AG | Laboratoires Urgo | 2006 | — |
| −1 | K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2007 | — |
| 0 (this device) | K100429 | Urgocell AG, Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061220 | Urgotul AGSummary page 1…or Usual Name: Antimicrobial Wound Dressing with Silver Proprietary Name: Urgocell®Ag Classification Name: Unclassified 3. Predicate Devices: Urgotul Ag (K061220), Laboratoires URGO Urgocell Ag (K062559), Laboratoires URGO 4. Description of Device Urgocell® Ag, antimicrobial wound dre… | 2006 |
| * | K062559 | Urgocell AG Antimicrobial Wound Dressing with SilverSummary page 1…with Silver Proprietary Name: Urgocell®Ag Classification Name: Unclassified 3. Predicate Devices: Urgotul Ag (K061220), Laboratoires URGO Urgocell Ag (K062559), Laboratoires URGO 4. Description of Device Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 14 ancestors has a recall.
- 2 other devices also cite its predicate K061220.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
The barrier functions of Urgocell Ag, antimicrobial wound dressing with silver, may help reduce* infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100429: Urgocell AG, Antimicrobial Wound Dressing with Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100429
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026